The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Verismo Segmentation Tool V.2.0.
| Device ID | K101697 |
| 510k Number | K101697 |
| Device Name: | ENSITE VERISMO SEGMENTATION TOOL V.2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | ST. JUDE MEDICAL 177 EAST COUNTY ROAD B St. Paul, MN 55117 |
| Contact | Kris Miller |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-16 |
| Decision Date | 2010-09-22 |
| Summary: | summary |